To determine safety,tolerability and activity of K0706 in subjects with chronic myeloid leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Phase 1
- Conditions
- Health Condition 1: null- Chronic myeloid leukemia
- Registration Number
- CTRI/2017/03/008178
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Willing and able to give written, and dated, informed consent (or legally acceptable
representative/impartial witness when applicable) and is available for the entire study
- Willing and able to comply with the scheduled visits
- Male or female aged 18 to 65 years (both inclusive)
- Minimum life expectancy of at least 12 months in the Investigator’s opinion
Exclusion Criteria
- Any major surgery
- Blood transfusion within 4 weeks of IMP administration
- Inability to swallow oral medication
- Inability to undergo venipuncture and/or tolerate venous access
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated doseTimepoint: 28 days
- Secondary Outcome Measures
Name Time Method Cmax, AUC, TmaxTimepoint: 24 hours